The following data is part of a premarket notification filed by De Gotzen S.r.l with the FDA for X-mind Trium.
| Device ID | K191719 |
| 510k Number | K191719 |
| Device Name: | X-MIND Trium |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | de Gotzen S.R.L via Roma, 45 Olgiate Olona, IT 21057 |
| Contact | Dario Bandiera |
| Correspondent | Dario Bandiera de Gotzen S.R.L via Roma, 45 Olgiate Olona, IT 21057 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-26 |
| Decision Date | 2020-02-20 |